Clinical Trial Finder

Inclusion Criteria.

• - Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.

• - Age ≥ 2 to < 18 years of age.

• - Diagnosis of gMG defined as: - Positive serologic test for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody (Ab) titers as confirmed at screening (1 retest allowed), and.

• - At least 1 of the following: - History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or.

• - History of positive anticholinesterase test (eg, edrophonium chloride test); or.

• - Participant demonstrated improvement in gMG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or.

• - Clinical syndrome consistent with a diagnosis of gMG, and not otherwise explained by another condition.

• - Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at the time of screening.

• - Quantitative Myasthenia Gravis score of 11 or greater at screening.

• - Participants may enter the study on: - Corticosteroids only, with no dose increase within 4 weeks prior to screening, or.

• - One allowed non-steroidal immunosuppressive therapies (IST) (azathioprine, mycophenolate mofetil, or mycophenolic acid) with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening, or.

• - Combination of (1) corticosteroids with no dose increase within 4 weeks prior to screening and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening.

• - Participants may enter the study on a stable dose of acetylcholinesterase inhibitors (pyridostigmine dose).

The acetylcholinesterase inhibitor dose must have been stable for at least 2 weeks prior to enrollment.

• - Vital signs and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the investigator.

Exclusion Criteria.

• - Thymectomy within 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the treatment period.

• - Unresected thymoma- Participants with benign thymoma resected > 12 months prior to screening may enroll.

• - History of recurrent significant infections.

• - Known immunodeficiency disorder, including current infection or positive test for human immunodeficiency virus (HIV).

• - Positive test for chronic hepatitis B infection at screening.

• - History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV).

• - History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines.

• - Receipt of any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) or any experimental B-cell-depleting agent in the 6 months prior to screening.

• - Receipt of any other monoclonal antibody (mAb) or large molecule biologic, including but not limited to FcRn inhibitors, anti-TNF mAbs, anti-janus kinase (JAK) Stat mAbs, and complement inhibitors within 6 months prior to screening.

• - Participants who are pregnant or breastfeeding or planning to get pregnant.

Arms

Experimental: Inebilizumab

Inebilizumab will be administered intravenously (IV).

Interventions

Drug: - Inebilizumab

Inebilizumab will be administered IV.